BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GATEWAY BALLOON CATHETER

    MDR report key: 2212348 · Received August 15, 2011

    Report

    Report Number
    2939204-2011-00407
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 26, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    GBA
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM THE USER FACILITY STATED THAT THERE WAS NO DEVICE MALFUNCTION AND THE PATIENT DID WELL POST PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. VASOSPASM AND VESSEL DISSECTION ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE LISTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    FOLLOWING ANGIOPLASTY TO TREAT THE STENOTIC LESION, ANGIOGRAPHY DEMONSTRATED POOR FLOW THROUGHOUT THE BASILAR ARTERY REPRESENTING A VASOSPASM AND VERAPAMIL WAS INFUSED (DOSE UNKNOWN). ANGIOGRAPHY TAKEN AFTER THE VERAPAMIL INFUSION DEMONSTRATED IMPROVED FLOW WITHIN THE BASILAR ARTERY, HOWEVER, A SIGNIFICANT FOCAL DISSECTION AT THE SITE OF THE PRIOR STENOSIS WAS NOTED. A STENT WAS EMERGENTLY IMPLANTED TO TREAT TO DISSECTION SUCCESSFULLY. ANGIOGRAPHY POST STENT DEPLOYMENT DEMONSTRATED GOOD WALL APPOSITION AT THE DISSECTION AND EXCELLENT FLOW IN THE BASILAR ARTERY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT AS A RESULT OF THE EVENTS.

    Description of Event or Problem · 1

    FOLLOWING ANGIOPLASTY TO TREAT THE STENOTIC LESION, ANGIOGRAPHY DEMONSTRATED POOR FLOW THROUGHOUT THE BASILAR ARTERY REPRESENTING A VASOSPASM AND VERAPAMIL WAS INFUSED (DOSE UNKNOWN). ANGIOGRAPHY TAKEN AFTER THE VERAPAMIL INFUSION DEMONSTRATED IMPROVED FLOW WITHIN THE BASILAR ARTERY, HOWEVER, A SIGNIFICANT FOCAL DISSECTION AT THE SITE OF THE PRIOR STENOSIS WAS NOTED. A STENT WAS EMERGENTLY IMPLANTED TO TREAT TO DISSECTION SUCCESSFULLY. ANGIOGRAPHY POST STENT DEPLOYMENT DEMONSTRATED GOOD WALL APPOSITION AT THE DISSECTION AND EXCELLENT FLOW IN THE BASILAR ARTERY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT AS A RESULT OF THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATEWAY BALLOON CATHETER CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MAPLE GROVE UNK533

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention